Neospasmina noc

Package Leaflet: Information for the Patient

NEOSPASMINA NOC, 3.15 ml/15 ml, Syrup

Fluid extract composed of: Hawthorn fruit, Valerian root, Hop flower, Passionflower herb

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 14 days, a doctor should be consulted.

Package Leaflet Contents

• 1. What is Neospasmina Noc and what is it used for
• 2. Important information before using Neospasmina Noc
• 3. How to use Neospasmina Noc
• 4. Possible side effects
• 5. How to store Neospasmina Noc
• 6. Package contents and other information

1. What is Neospasmina Noc and what is it used for

Traditional herbal medicinal product for use in the indications listed, resulting solely from its long-term use.
Neospasmina Noc is a traditional herbal medicinal product that contains a liquid extract composed of hawthorn fruit, valerian root, hop cones, and passionflower herb in its composition.
The medicine has a mild sedative effect and facilitates falling asleep.

Indications for use:

Traditional herbal medicinal product used as an adjunct in the treatment of:

• nervous disorders such as mild tension states and feelings of anxiety
• difficulty falling asleep.

2. Important information before using Neospasmina Noc

When not to use Neospasmina Noc

• if the patient is allergic to hawthorn fruit, valerian root, hop cones, passionflower herb, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Neospasmina Noc, the doctor or pharmacist should be consulted.
The medicine should not be used in patients with brain damage and mental illnesses.

Children and adolescents

Use in children and adolescents under 18 years of age is not recommended due to the lack of data.
In children from 6 to 12 years and adolescents, the medicine should be used under the supervision of a doctor. Due to the alcohol content (ethanol) of the medicine, it should not be used in children under 6 years of age.

Neospasmina Noc and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any medicines the patient plans to use.
Concomitant use with synthetic sedatives is not recommended.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to the ethanol content of the medicine, it should not be used during pregnancy and breastfeeding.
There are no data on the effect of the product on fertility.

Driving and using machines

The medicine may impair the ability to drive and use machines. Patients using the medicine should not drive or operate machines.
The medicine contains up to 10% (V/V) ethanol. A single dose contains 1200 mg of alcohol in each 15 ml of syrup.

Neospasmina Noc contains sucrose, ethanol, sodium benzoate (E 211), and sodium

The medicine contains 10 g of sucrose in 15 ml of syrup (13 g of sucrose in 20 ml of syrup; 40 g of sucrose in 60 ml of syrup). If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine. This should be taken into account in patients with diabetes.
The medicine may have a harmful effect on teeth.
This medicine contains 1200 mg of alcohol (ethanol) in each 15 ml of syrup (1600 mg of alcohol (ethanol) in each 20 ml of syrup; 4800 mg of alcohol (ethanol) in each 60 ml of syrup). The amount of alcohol in this medicine is equivalent to 30 ml of beer or 12 ml of wine per 15 ml of syrup (40 ml of beer or 16 ml of wine per 20 ml of syrup; 120 ml of beer or 48 ml of wine per 60 ml of syrup).
The alcohol in this medicine may affect children. Symptoms may include: drowsiness and changes in behavior. It may also affect their ability to concentrate and engage in physical activity.
If the patient has epilepsy or liver problems, the doctor or pharmacist should be consulted before using the medicine.
The alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, the doctor or pharmacist should be consulted.
If the patient is pregnant or breastfeeding, the doctor or pharmacist should be consulted before using this medicine.
If the patient is addicted to alcohol, the doctor or pharmacist should be consulted before using this medicine.
The medicine contains 37.5 mg of sodium benzoate (E 211) in 15 ml of syrup (50.4 mg of sodium benzoate in 20 ml of syrup; 151 mg of sodium benzoate in 60 ml of syrup).
The medicine contains less than 1 mmol (23 mg) of sodium per 15 ml and 20 ml of syrup, which means the medicine is considered "sodium-free".

3. How to use Neospasmina Noc

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Neospasmina Noc is intended for symptomatic treatment.
Oral administration.
Adults:

• as an adjunct in the treatment of nervous disorders such as mild tension states and feelings of anxiety: a single dose of 15 ml (corresponding to 18.9 g) of syrup to be taken 2 to 3 times a day;
• -as an adjunct in the treatment of difficulty falling asleep: a single dose of 20 ml (corresponding to 25.2 g) of syrup to be taken half an hour to an hour before bedtime.

Maximum dose: 4 single doses (60 ml).
If symptoms persist for more than 14 days during treatment, a doctor or other qualified healthcare professional should be consulted.

Using a higher dose of Neospasmina Noc than recommended

Valerian root in doses greater than 20 g (corresponding to 261.3 ml of syrup) may cause mild symptoms (fatigue, abdominal cramps, dizziness, chest tightness, hand tremors, and pupil dilation), which usually resolve within 24 hours.
In the event of the above symptoms, supportive treatment should be applied.

Missing a dose of Neospasmina Noc

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Neospasmina Noc

Neospasmina Noc is intended for use when symptoms occur.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Neospasmina Noc can cause side effects, although not everybody gets them.
During the use of products containing valerian root, gastrointestinal disorders (e.g., nausea, abdominal cramps) may occur. Frequency not known.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Neospasmina Noc

Store in a tightly closed container, at a temperature not exceeding 25°C.
Opalescence with possible formation of plant-based sediment may occur.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Neospasmina Noc contains

• The active substance is a liquid extract composed of hawthorn fruit, valerian root, hop cones, and passionflower herb. 100 g of syrup contains: 17 g of liquid extract (1:1) of Crataegus monogynaJacq.(Lindm.); Crataegus laevigata(Poir.) D.C. fructus(hawthorn fruit) / Valeriana officinalisL., radix(valerian root) / Humulus lupulusL., flos(hop cones) / Passiflora incarnataL., herba(passionflower herb) (36/36/18/10). Extractant: ethanol 50% (V/V).
• Other ingredients are: sucrose, sodium benzoate (E 211), orange essence, purified water. The medicine contains up to 10% (V/V) ethanol.

What Neospasmina Noc looks like and contents of the pack

Brown glass bottle with a polyethylene cap, 30 ml measuring cup in a cardboard box.
1 bottle of 119 ml

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

„Herbapol-Lublin” S.A.
ul. Diamentowa 25, 20-471 Lublin

Date of last revision of the package leaflet: